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510(k) Data Aggregation
(28 days)
Freedom Primary PCK
The Freedom® Primary PCK is designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System, and is indicated for the following:
· Severe knee joint pain, loss of mobility due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
· Correction of functional deformities.
· Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- · Moderate valgus, varus, or flexion trauma.
- · Knee fractures untreatable by other methods
· Revision surgery where sufficient bone stock and soft tissue integrity are present
The Freedom® Primary PCK is intended for cemented use only. This device is for single use only.
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I apologize, but the provided text from the FDA 510(k) clearance letter for the "Freedom Primary PCK" knee prosthesis does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device.
The document is a clearance letter for a physical medical device (a knee implant) and focuses on regulatory aspects like substantial equivalence to predicate devices, general controls, and indications for use. It does not mention any AI/ML components, performance metrics, or clinical study data related to an AI/ML algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Training set sample size.
- Ground truth establishment for the training set.
These details are typically found in the clinical study report or performance evaluation section of a submission for an AI/ML-driven device, which is not present in this regulatory clearance letter for a knee implant.
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